The present invention relates to a pharmaceutical composition for prevention and/or treatment of premature ejaculation and/or hypersensitivity of sexual stimulation, more particularly to the pharmaceutical composition containing a purified essence of Sumsoo (Bufonis venenum) for prevention and/or treatment of dysspermia or the symptom of non-controlled ejaculation in male, due to premature ejaculation and/or hypersensitivity of sexual stimulation.
In general, a hypersensitivity of sexual stimulation has been known as being caused by the failure or disorder of the complicated cooperation between the peripheral and central nerve system. In particular, the term xe2x80x9chypersensitivity of sexual stimulationxe2x80x9d denotes a symptom that when a man has a sexual intercourse with a woman, he ejaculates immediately before or after his penis is introduced into the virginal speculum of the woman, or even cannot control his penis to keep the erection state and/or the ejaculation for a sufficient time period for providing the woman with a sexual satisfaction, in the majority cases of their sexual intercourse.
According to the recent statistical report in Korea, approximately 30 to 50% of adult men have been troubled with such unsatisfactory sexual ability resulted from the sexual hypersensitivity. Therefore, it has become a social problem due to the friction between a husband and wife and a loss of confidence and/or the resulted enervation.
The various causes of the symptom of sexual hypersensitivity have been reported, such as a functional reduction of central nerve due to the fatigue of neuro-transmitter system, a hypersensitive response of the urinary duct or the galns receptor, the endocrinal problem, the mental cause and so forth. However, it was recently deduced that since the above-mentioned causes may react on the nerve system in simultaneous and complex manner, or a cooperation system between the central sexual nerve system in a man may be disrupted, a reflective ejaculation can easily be caused.
A therapy of the symptom of sexual hypersensitivity may be classified as a mental therapy and a medicinal therapy. The mental therapy may be used to overcome the problem through the training a sexual technique for a long term with the conversation and cooperation among a physician, the patient and his sex partner. However, since this method requires a long term and a complicated process for treatment, a high amount of cost for the therapy, and an effect of circumstance such as the additional stress from outside, and a maintenance of the cooperation system is difficult for those reasons, the patients do not prefer the method due to the possible failure of treatment or the re-occurrence of the symptom. In particular, it is reported that the therapy merely results in not more than approximately 50% of success.
In practice, since the medicinal therapy is known as being more effective than the mental therapy in an aspect of the level and immediateness of the resulting effect, it is widely used for purpose of treatment of the symptom. A drug or agent used in the medicament therapy includes a psychotropic agent such as antidepressant suppressing an excitation of the central sexual nerves, and a topical anesthetic, which can delay the ejaculation time point by making the peripheral sexual nerve less sensitive. However, in case of central nerve-suppressing agent, a sexual intercourse itself may be impossible due to the loss of sexual desire, while in case of peripheral nerve-suppressing agent, a effective term of a topical anesthetic such as Lidocaine ointment or spray is so short that it must be used immediately before the sexual intercourse. In this connection, those agents could not provide a successful solution for treatment of sexual hypersensitivity.
Therefore, the various research and studies have been made to develop a successful agent for treatment of sexual hypersensitivity, and a scientific approach and the severe efforts are also made for providing a useful therapeutic method to be accepted as an excellent agent in the medical field.
A typical formulation of pharmaceutical agent has been disclosed in the trademark of SS Cream (KR Patent 0148511 owned by the applicant), whose effect has been verified as being the successful therapeutic agent for treating sexual hypersensitivity. It was a medicine for external application prepared by using nine kinds of herb extracts as the main components, such as Ginseng, Dang-gui, Sasangja, Sancho (Chinese Pepper), Yuk-Jong-Yong, Cinnamon, Sesin, Clove (Jeong-Hyang) and Bufonis venenum, which can prevent the hypersensitivity of sexual nerve by their own topical anesthetic effect.
However, as a result of search for the effect of the said formulation among the consumers who have ever used SS Cream, most of them complained of a topical fever, a pain, impotency and so forth. Furthermore, the smell from the herb components was so strong that they could not continuously use the product.
The present inventors have studied and tested intensively and extensively in order to overcome those problems, and found out that the component of Bufonis venenum, which is an ingredient secreted from the venom gland of toad, was the main component providing the side effects as well as the effect of treating the hypersensitivity of sexual nerve; and therefore, even if the component of Bufonis venenum were solely contained as the active component in a properly purified from, with extruding the other components from the therapeutic agent, the therapeutic effect of the hypersensitivity of sexual nerve being equivalent to the prior art can be maintained without the side effects caused by Bufonis venenum. On the basis of these, the inventors completed the present invention.
The present invention provides a pharmaceutical composition for treatment and prevention of the hypersensitivity of sexual nerve in male.
According to a teaching of the old Chinese pharmaceutical recipes, Bufonis venenum is secreted from the venom gland of toad, has the pharmacological effects of cardiotonic, tonic, urination, alleviation, detoxification and so forth, and is an effective component of medicine for treating premature ejaculation by topical application as well as throatache, toothache and detoxification.
However, Bufonis venenum is a kind of violent poison, and a certain cases of poisoning due to wrong or incorrect use has occasionally been reported. Therefore, the various methods had been proposed in order to reduce such violent poison. In the prior art, especially in case of SS Cream, many kinds of herb extract components seemed to have been added in order to reduce such violent poison, resulting in the problem of a unique and strong smell.
In this regard, the object of the present invention was accomplished by providing a method for purification and isolation/separation of the pharmacological component effective for treatment of premature ejaculation and/or hypersensitivity of sexual stimulation and extrude the toxic components presenting a symptom of pain; and a recipe or use including a dose and a route of administration.
Bufonis venenum used in the present invention for prevention or treatment of premature ejaculation and/or hypersensitivity of sexual stimulation may be a purified essence, which was extracted by using one or more organic solvent selected from a group consisting of ethyl acetate, dichloremethane and chloroform, and concentrated. The said purified essence of Bufonis venenum may be one which was purified and fractionated by using silica gel column.
Also, the pharmaceutical composition for prevention or treatment of premature ejaculation and/or hypersensitivity of sexual stimulation according to the present invention is not limited in the form of product, if it can be formulated for using in the topical administration. Specifically, the product of the invention can be in the various medicinal form, such as ointment, suspension, gel, spray, patch or solution.